From Frances Zammit
How are human trials of potentially powerful drugs targeted at the immune system made safer by initially giving them to a single volunteer (29 July, p 5)? The trial and the drug remain just as hazardous for the single volunteer as they would be for six or seven. The only possible way to make it safer would be for regulations to require the single volunteer to be the CEO of the trial’s funding body.
The editor writes:
• Due to lack of space we were unable to print the details of the UK Department of Health recommendations. Its interim report suggests that “the first dose should be given to one person only, leaving sufficient time for any adverse reaction to develop before further doses or administration to more people; in some circumstances and particularly if the drug is to affect the immune system, first studies may more appropriately involve patients being treated for the disease rather than healthy volunteers.”
Bristol, UK
